Longhorn Vaccines and Diagnostics LLC

Bethesda, MD, US

Longhorn Vaccines and Diagnostics LLC appears in FDA device records in Bethesda, MD. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of 2026-09-10, FDA records show one recall for this company, and at least one establishment registration is current.

510(k) clearances: 1
PMA records: 0
Recall records: 1
Registered establishments: 1

FDA records under these names

1 name

FDA records resolved to Longhorn Vaccines and Diagnostics LLC carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

LONGHORN VACCINES AND DIAGNOSTICenforcement report, recall

510(k) clearance history

FDA records hold 1 510(k) clearance for Longhorn Vaccines and Diagnostics LLC in 2018.

Clearances by year, as a table

510(k) clearance decisions for Longhorn Vaccines and Diagnostics LLC, by decision year
Year	Clearances
2018	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
DEN170029	PrimeStore MTM	QBD	Unknown	2018-03-19

Registered establishments

FDA registered establishments for Longhorn Vaccines and Diagnostics LLC, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
3011818318	3011818318	Longhorn Vaccines and Diagnostics LLC	7272 Wisconsin Avenue, Bethesda, MD 20814 US	2026	QBD

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

QBDMicrobial Nucleic Acid Storage And Stabilization Device

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-2952-2020	PrimeStore Molecular Transport Medium (PS-MTM), Model Numbers LH-1-2, LH-1-3, LH-1-4, LH-1-5, LH-1-5CC, LH-1-15CC - Product Usage: intended for stabilization, transportation, and inactivation of infectious unprocessed nasal washes, nasopharyngeal, oral/throat swabs* suspected of containing Influenza A virus RNA. PS-MTM is also intended for the stabilization, transportation, and inactivation of infectious unprocessed sputum samples suspected of containing Mycobacterium tuberculosis (MTB) DNA from human samples.	The tubes may have been delivered to some users without labels. Users may not be able to identify the tubes without these labels. If samples stored or transported in tubes are tested on certain systems or come into contact with bleach they can produce cyanide gas. The solution in these tubes contains guanidine thiocynate and may put laboratory personnel at risk of exposure to cyanide gas when it comes into contact with bleach or reagents containing bleach.	Class II	2020-06-03	Open, Classified

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain